Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning the following products:

• DC Bead M1 Embolic Drug Eluting Bead 70-150 µm
  • UPN#: DC2V001
  • Incorrect UPN# on Label: BS-DC2V001
  • GTIN: 05060116920215
  • Lot/ Batch #: 7003285-1
  • Expiration Date: 31 Oct 2023
• DC Bead Drug Delivery Embolisation System 100-300 µm
  • UPN#: DC2V103
  • Incorrect UPN# on Label: BS-DC2V103
  • GTIN: 05060116920109
  • Lot/ Batch #: 7003059-8, 7003098-9, 7003227-1
  • Expiration Date: 31 Jul 2023, 31 Aug 2023, 31 Oct 2023
• DC Bead Drug Delivery Embolisation System 300-500 µm
  • UPN#: DC2V305
  • Incorrect UPN# on Label: BS- DC2V305
  • GTIN: 05060116920116
  • Lot/ Batch #: 7002766-6, 7002975-18
  • Expiration Date: 30 Apr 2023, 31 Jul 2023
• DC Bead LUMI Radiopaque Embolic Drug-eluting Bead 70-150µm
  • UPN#: R02D001
  • Incorrect UPN# on Label: BS- R02D001
  • GTIN: 05060116921090
  • Lot/ Batch #: 7003840-6, 7003914-6
  • Expiration Date: 31 Jul 2022, 31 Aug 2022

The manufacturer is conducting a removal of specific lots of the above-mentioned products due to an incorrect Chinese label printed on the packaging of the products. The UPN printed on the Chinese label contains an unnecessary "BS-" prefix, which should not be present.

According to the manufacturer, there is no adverse health consequence. The manufacturer is advising affected users to identify and segregate all affected product and return the product if it has the incorrect "BS-" prefix.

According to the local supplier, the affected products are NOT distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 February 2021